NL-OMON54543
Recruiting
Not Applicable
Fluid hydration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis: the FLUYT-prevent trial. a multicenter randomized controlled superiority trial.;Pancreatic duct stent placement to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients with unintended PD-wire cannulation: a multicenter prospective cohort - FLUYT-prevent trial FLUYT -2-PDS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- post-ERCP pancreatitis
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 1108
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 85
- •written informed consent
Exclusion Criteria
- •1\) Allergy to NSAID\*s or other contraindications 2\) Ongoing acute pancreatitis
- •3\) Ongoing hypotension, including those with sepsis 4\) Cardiac insufficiency
- •(\>NYHA Class I heart failure) 5\) Renal insufficiency (RI, GFR \<30ml/min) 6\)
- •Active ulcer disease 7\) Severe liver dysfunction: Liver cirrhosis and currently
- •ascites 8\) Respiratory insufficiency (pO2\<60mmHg or 90% despite FiO2 of 30% or
- •requiring mechanical ventilation). 9\) Pregnancy 10\) Hyponatremia (Na\+ levels \<
- •130mmol/l) 11\) Hypernatremia (Na\+ levels \> 150mmol/l) 12\) Oedema 13\) Low risk
- •of PEP: chronic calcific pancreatitis (according to M\-ANNHEIM criteria) with a
- •CBD intervention (PD intervention is allowed \-\-\> not in FLUYT\-2\-PDS); or
- •pancreatic head mass; or routine biliary stent exchange; or re\-ERCP with a
Outcomes
Primary Outcomes
Not specified
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